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The Effect of Orthopedic Face Mask Use on Head Posture and Pharyngeal Airway

Primary Purpose

Class III Malocclusion, Hyoid Bone

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Skeletal Class III Malocclusion Treatment with Face Mask Group
Sponsored by
Taner OZTURK, DDS, MS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Class III Malocclusion focused on measuring Class III Malocclusion, Craniocervical Posture, Hyoid Bone Position, Pharyngeal Airway

Eligibility Criteria

8 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • For the study group it is as follows:

    1. Patients with skeletal Class III association (ANB < 0°)
    2. Maxillary insufficiency patients
    3. Patients with ongoing growth development
    4. Patients who have used a 'Petit type face mask' for anterior positioning of the maxilla
  • For the control group it is as follows:

    1. Patients with skeletal Class III association (ANB < 0°)
    2. Maxillary insufficiency patients
    3. Patients with ongoing growth development
    4. Patients who have not had any orthodontic treatment

Exclusion Criteria:

  1. Patients with a congenital anomaly or a craniofacial deformity
  2. Patients who have undergone orthodontic treatment
  3. Patients with tooth extraction or tooth loss
  4. Patients with a history of trauma
  5. Patients who have completed growth development (patients with Ru on wrist film)

Sites / Locations

  • Erciyes University Faculty of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Skeletal Class III Malocclusion Treatment with Face Mask Group

Control Group

Arm Description

In patients with skeletal class III malocclusion (ANB angle < 0,0) due to maxillary deficiency, rapid maxillary expansion appliances prepared on dental plaster models made of acrylic material covering all the upper dental posterior tooth surfaces were applied before the upper jaw was orthopedically brought forward with a face mask. This process was stopped when the expansion was made so that the palatal tubercles of the maxillary permanent first molars align with the buccal tubercles of the mandibular permanent first molars. Immediately afterwards, the petit-type face mask was applied to the hooks of the maxillary expansion device with the help of elastic bands and used continuously for at least 18 hours a day. After obtaining a positive overjet, the face mask appliance was used at night to ensure retention, and then the treatment was terminated.

A control group was formed from patients in the same age group who had skeletal class III malocclusion due to maxillary growth deficiency but were not treated. In this way, the changes that occurred in the normal process in the head, craniocervical postures, pharyngeal airway and hyoid bones of the patients whose growth and development continued could be distinguished.

Outcomes

Primary Outcome Measures

Craniocervical posture change
Investigation of the change in head posture after treatment of class III malocclusion due to maxillary deficiency with a face mask using craniocervical angles (NSL/CVT, NSL/OPT, CVT/HOR, OPT/HOR, NL/VER, NSL/VER).
Pharyngeal airway change
Investigation of the change in pharyngeal airway dimensions after treatment of class III malocclusion due to maxillary deficiency with a face mask using pharyngeal airway sagittal dimension measurements (PNS-UPW, Cv2-MPW, Cv3-LPW, HRL/U-PNS, U-PNS, PASmin).
Hyoid bone position change
Investigation of the change in hyoid bone position after treatment of class III malocclusion due to maxillary deficiency with a face mask using hyoid bone location measurements (H-Cv2, H-Cv3, H-Mandibular line, H-Me).

Secondary Outcome Measures

Correlation of craniocervical posture, pharyngeal airway and hyoid bone change
Investigation of the relationship between changes in craniocervical posture, pharyngeal airway dimensions and hyoid bone position.

Full Information

First Posted
October 19, 2021
Last Updated
October 29, 2021
Sponsor
Taner OZTURK, DDS, MS
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1. Study Identification

Unique Protocol Identification Number
NCT05114642
Brief Title
The Effect of Orthopedic Face Mask Use on Head Posture and Pharyngeal Airway
Official Title
Evaluation of the Effect of Face Mask Treatment on Head Posture, Pharyngeal Airway, Skeletal and Dental Structures in Patients With Maxillary Retrognathia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
November 30, 2019 (Actual)
Primary Completion Date
October 30, 2020 (Actual)
Study Completion Date
March 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Taner OZTURK, DDS, MS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study was to evaluate the changes in head posture, position of the hyoid bone, pharyngeal airway and cervical posture after the use of Petit type face mask in patients with skeletal class III malocclusion (ANB angle < 0) with ongoing growth. No other study was found in the literature in which head posture, cervical posture, and hyoid bone position were evaluated after the use of a face mask and compared with a control group consisting of patients of the same age group and the same malocclusion.
Detailed Description
All radiographic assessments, including cephalometric, pharyngeal airway and craniocervical measurements were performed by the same researcher and she was blind to all the treatment details, orthodontic records, and information of the subjects to prevent bias. Lateral cephalometric radiographs were taken digitally with an X-ray unit (OP300; Instrumentarium Dental, Tuusula, Finland) according to the manufacturer and same technician. Subjects were positioned at the natural head position, teeth in centric occlusion, and lightly closed lips for lateral cephalometric radiographs. Skeletal development of individuals was evaluated using cervical vertebra maturation method (Ref: Bacetti T., An Improved Version of the Cervical Vertebral Maturation (CVM) Method for the Assessment of Mandibular Growth. Angle Orthod.). The skeletal development of individuals was evaluated using the cervical vertebra maturation method and it was determined that all patients were in the prepubertal stage (CS1-CS3). (Ref: Cevidanes L., Comparison of two protocols for maxillary protraction: bone anchors versus face mask with rapid maxillary expansion. Angle Orthod.)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Class III Malocclusion, Hyoid Bone
Keywords
Class III Malocclusion, Craniocervical Posture, Hyoid Bone Position, Pharyngeal Airway

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Head posture on lateral cephalometric radiographs taken before and after the application of the rapid maxillary expansion device with hooks to the upper dental arch and the Petit type face mask treatment applied after the skeletal class III patients due to maxillary retrognathia, whose growth development continues, for treatment to the Orthodontics Department of the Faculty of Dentistry, cervical posture, pharyngeal airway, and hyoid bone positions are determined.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Skeletal Class III Malocclusion Treatment with Face Mask Group
Arm Type
Experimental
Arm Description
In patients with skeletal class III malocclusion (ANB angle < 0,0) due to maxillary deficiency, rapid maxillary expansion appliances prepared on dental plaster models made of acrylic material covering all the upper dental posterior tooth surfaces were applied before the upper jaw was orthopedically brought forward with a face mask. This process was stopped when the expansion was made so that the palatal tubercles of the maxillary permanent first molars align with the buccal tubercles of the mandibular permanent first molars. Immediately afterwards, the petit-type face mask was applied to the hooks of the maxillary expansion device with the help of elastic bands and used continuously for at least 18 hours a day. After obtaining a positive overjet, the face mask appliance was used at night to ensure retention, and then the treatment was terminated.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
A control group was formed from patients in the same age group who had skeletal class III malocclusion due to maxillary growth deficiency but were not treated. In this way, the changes that occurred in the normal process in the head, craniocervical postures, pharyngeal airway and hyoid bones of the patients whose growth and development continued could be distinguished.
Intervention Type
Device
Intervention Name(s)
Skeletal Class III Malocclusion Treatment with Face Mask Group
Other Intervention Name(s)
Maxillary expansion
Intervention Description
Expanding the maxilla, which is narrower than the mandible in the transverse dimension, using a rapid maxillary expansion device and protraction of the maxilla, which is located behind in the sagittal dimension, forward using the face-mask appliance.
Primary Outcome Measure Information:
Title
Craniocervical posture change
Description
Investigation of the change in head posture after treatment of class III malocclusion due to maxillary deficiency with a face mask using craniocervical angles (NSL/CVT, NSL/OPT, CVT/HOR, OPT/HOR, NL/VER, NSL/VER).
Time Frame
Before treatment (T0) and after treatment (up to about 10-12 month; T1) for the study group. First measurement (T0) for the control group and after similar follow-up time (up to about 10-12 month; T1) as for the treatment group.
Title
Pharyngeal airway change
Description
Investigation of the change in pharyngeal airway dimensions after treatment of class III malocclusion due to maxillary deficiency with a face mask using pharyngeal airway sagittal dimension measurements (PNS-UPW, Cv2-MPW, Cv3-LPW, HRL/U-PNS, U-PNS, PASmin).
Time Frame
Before treatment (T0) and after treatment (up to about 10-12 month; T1) for the study group. First measurement (T0) for the control group and after similar follow-up time (up to about 10-12 month; T1) as for the treatment group.
Title
Hyoid bone position change
Description
Investigation of the change in hyoid bone position after treatment of class III malocclusion due to maxillary deficiency with a face mask using hyoid bone location measurements (H-Cv2, H-Cv3, H-Mandibular line, H-Me).
Time Frame
Before treatment (T0) and after treatment (up to about 10-12 month; T1) for the study group. First measurement (T0) for the control group and after similar follow-up time (up to about 10-12 month; T1) as for the treatment group.
Secondary Outcome Measure Information:
Title
Correlation of craniocervical posture, pharyngeal airway and hyoid bone change
Description
Investigation of the relationship between changes in craniocervical posture, pharyngeal airway dimensions and hyoid bone position.
Time Frame
Before treatment (T0) and after treatment (up to about 10-12 month; T1) for the study group. First measurement (T0) for the control group and after similar follow-up time (up to about 10-12 month; T1) as for the treatment group.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: For the study group it is as follows: Patients with skeletal Class III association (ANB < 0°) Maxillary insufficiency patients Patients with ongoing growth development Patients who have used a 'Petit type face mask' for anterior positioning of the maxilla For the control group it is as follows: Patients with skeletal Class III association (ANB < 0°) Maxillary insufficiency patients Patients with ongoing growth development Patients who have not had any orthodontic treatment Exclusion Criteria: Patients with a congenital anomaly or a craniofacial deformity Patients who have undergone orthodontic treatment Patients with tooth extraction or tooth loss Patients with a history of trauma Patients who have completed growth development (patients with Ru on wrist film)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gokhan Coban, DDS, MDS
Organizational Affiliation
Erciyes University, Faculty of Dentistry, Department of Orthodontics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erciyes University Faculty of Dentistry
City
Kayseri
ZIP/Postal Code
38039
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12407940
Citation
Solow B, Sandham A. Cranio-cervical posture: a factor in the development and function of the dentofacial structures. Eur J Orthod. 2002 Oct;24(5):447-56. doi: 10.1093/ejo/24.5.447.
Results Reference
background
PubMed Identifier
30892615
Citation
Gul Amuk N, Kurt G, Baysal A, Turker G. Changes in pharyngeal airway dimensions following incremental and maximum bite advancement during Herbst-rapid palatal expander appliance therapy in late adolescent and young adult patients: a randomized non-controlled prospective clinical study. Eur J Orthod. 2019 May 24;41(3):322-330. doi: 10.1093/ejo/cjz011.
Results Reference
background
PubMed Identifier
17906307
Citation
Kilinc AS, Arslan SG, Kama JD, Ozer T, Dari O. Effects on the sagittal pharyngeal dimensions of protraction and rapid palatal expansion in Class III malocclusion subjects. Eur J Orthod. 2008 Feb;30(1):61-6. doi: 10.1093/ejo/cjm076. Epub 2007 Sep 28.
Results Reference
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The Effect of Orthopedic Face Mask Use on Head Posture and Pharyngeal Airway

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